MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-02-03 for PREVALON AIRTAP PATIENT REPOSITIONING SYSTEM WEDGES manufactured by Sage Products Llc.
[66474475]
Patient Sequence No: 1, Text Type: N, H10
[66474476]
The following concern was reported by the manager of an icu unit. Patient was alert and able to follow commands. All appropriate fall precautions in place prior to event. Pt had been placed in bed chair position and had recently been rounded up (5 minutes prior). Pt slid down bed as it was in bedchair position and landed on backside on floor. Only possible contributing factor noted was pt was on airtap device to assist with re-positioning. Possibly contributed to pt being able to slide down and out of bed. No injuries noted. The manager contacted the rep of the company and they said the airtap repositioning device was intended for lateral repositioning and has not been tested in the sitting position. In the education provided as an inservice from prevalon, the company did not specifically state that patients had to be flat or with head of bed within a certain number of degrees when using the product. The manager said the rep of prevalon airtrap would pass the information along to their quality assurance department.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6300045 |
| MDR Report Key | 6300045 |
| Date Received | 2017-02-03 |
| Date of Report | 2016-12-23 |
| Date of Event | 2016-12-20 |
| Report Date | 2016-12-23 |
| Date Reported to FDA | 2016-12-23 |
| Date Reported to Mfgr | 2016-12-23 |
| Date Added to Maude | 2017-02-03 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PREVALON AIRTAP PATIENT REPOSITIONING SYSTEM WEDGES |
| Generic Name | PROTECTOR, SKIN PRESSURE |
| Product Code | FMP |
| Date Received | 2017-02-03 |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SAGE PRODUCTS LLC |
| Manufacturer Address | 3909 3 OAKS ROAD CARY IL 60013 US 60013 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-02-03 |